The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis. A Two-arm Double-blind Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Shoulder pain
研究概览
简要总结
Adhesive capsulitis (AC) is a significant cause of chronic shoulder pain and disability. Non-surgical option consisting of intraarticular corticosteroid (IA CS) injection with structured physiotherapy (PT) is the current standard of care. More recent randomized controlled trials have found that rotator interval (RI) hydro-dissection approach leads to better improvement in pain as compared to IA approach. Despite being non-inferior to surgical management, long-term outcome studies of patients treated with IA CS injection and PT have shown that patients only achieve satisfactory outcomes in 72.3% of patients after a mean symptom duration of 41.8 months. Furthermore, CS injections are associated with significant systemic and local adverse effects such as Cushing syndrome, osteopenia/ osteoporosis, infection, and hyperglycemia. In recent years, dextrose injection has emerged as an effective alternative to CS-based injections to treat chronic painful musculoskeletal conditions such as chronic low back pain, peripheral nerve entrapment and lateral epicondylitis.
The investigators aim to study the effects of RI hydro-dissection with dextrose 5% (D5%) on pain relief, shoulder ROM and shoulder function in patients with primary AC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with primary adhesive capsulitis
- •aged 35 to 65 years of age
- •duration of symptoms in between 3 to 18 months
- •limitation in flexion, abduction, and external rotation greater than 30 degrees compared to normal
- •limitation in internal rotation with hand to back shoulder test below L4
排除标准
- •diagnosis of connective tissue disease or inflammatory arthritis
- •history of surgery to the affected shoulder
- •history of shoulder dislocation/ fracture
- •neurological weakness of the affected upper limb
- •ultrasound findings of rotator cuff or LHBT tendinopathy
- •plain radiographs showing significant glenohumeral joint osteoarthritis (Kallgren-Lawrence grade 3 or 4)
- •other sources of chronic pain
- •bilateral adhesive capsulitis
- •history of pain intervention to the shoulder joint in the past 3 months
- •allergic reaction to local anesthetic agent
研究组 & 干预措施
Dextrose 5%
Rotator interval hydro-dissection with dextrose 5% solution
干预措施: Rotator interval hydro-dissection with dextrose 5% (Drug)
Corticosteroid
Rotator interval hydro-dissection with corticosteroid solution
干预措施: Rotator interval hydro-dissection with corticosteroid solution (Drug)
结局指标
主要结局
Shoulder pain
时间窗: 1 week, 4 weeks and 12 weeks post injection
Shoulder pain based on Shoulder Pain and Disability Index (SPADI) pain scale. The SPADI pain scale ranges from 0 to 50, with higher score indicating greater level of pain.
次要结局
- Shoulder range of motion(4 weeks and 12 weeks post injection)
- Shoulder function(4 weeks and 12 weeks post injection)